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Rehabilitation chair JUMBO

Use and Maintenance Instruction

First class medical product according to the Regulation 93/42/EWG of European Parliament and Council regarding medical products. For this

product the producer issued relevant declaration of conformity. Producer’s identification number in the Registration Department of

Healing, Medical and Biocide Products:

PL/CA01 04088/W

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INTRODUCTIONTaking sitting position by disable child from early stage of life

is the significant part of the rehabilitation process. It has very important, positive influence on child’s development and improvement of motor skills. Independent, safe sitting of a child that has lost the ability of independent locomotion as a result of illness or accident, has positive influence of patient’ as well as care people psyche.

Elephant is a device designed to be used in the process of daily rehabilitation of patients with illness which makes independent sitting or standing impossible.

Usage of wood, colorful upholstery, bright colors and figure of elephant make the chair more a toy for children than a rehabilitation device.

It is a universal device; flaccid children as well as children with muscle tone and spastic children can be sited in it. The device improves comfort of life of the child and child’s family.

Please, read this instruction carefully. Here you will find information about our product and learn how to use it safely and effectively.

In case of any questions, please contact our medical consultant (ph. 0048 508 382 509) or directly our office (ph. 0048 17 864 0470)

Before the first use of the product the user is obliged to read this instruction.Please, remember that following the instruction allows for safe use of the product, lengthens its life and esthetics.

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3445566679101213

9001

13485

CONTENT

1. Sitting up as relevant element of the process of rehabilitation.................2. When to use the Elephant.........................................................................3. Technical specification.............................................................................4. Standard equipment of the chair Elephant...............................................5. Optional equipment of the chair Elephant ..............................................6. Sitting up of the patient............................................................................

Preparation of the patient................................................................Preparation of the device................................................................Adjusting of the device to the patient.............................................

7. Safety rules..............................................................................................8. Maintenance and cleaning.......................................................................9. Responsibility of the producer.................................................................10. Conditions guarantee....................................................................

Akces-Med Sp. z o.o. Company introduced quality management system ISO 9001:2000 and ISO 13485:2003 regarding production, sales and service. The system is certified by Det Norske Veritas.

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1. Sitting up as relevant element of the process of rehabilitation.

Clinical tests show how important for the patient is to be placed in sitting position every day. Systematic placing of the patient in upright position is a significant part of the process of rehabilitation and has positive influence on correct functioning of many organs and systems; often it is a preliminary stage before learning to walk:

- the most important outcome when using the chair in case of children is stimulation of psycho-motor development- significant improvement of psychological condition of the patient- better development of muscles, joints and musculoskeletal system- prevention and healing of joint and muscle contractions, improvement of joint movement- prevents muscle decline- enables exercise of upper limbs in sitting position- improves functioning of cardio-vascular system- improves air exchange in lungs – pneumonia prevention - improves peristalsis of intestines- prevents and helps in treatment of urinary system stasis, helps in restoring the functions of neurogenic bladder- prevents and heals bedsores- passive sitting is usually only a stage of rehabilitation before the patient starts learning to walk and gains more independence

ATTENTION: Decision to use Elephant chair is always made by the doctor in charge.

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size 1

15-2715-2742-62

17-3413-3130 kg

2

22-3322-3348-69

23-4418-3845 kg

2. When to use the Elephant

a) As an individual rehabilitation device – permanent supply- infantile cerebral palsy, tetraplegia, paresis o flower limbs, flaccid and spastic children- brain and spinal cord damage with atony of limbs, balance and coordination disorder- myelomeningocele

b) As rehabilitation device in intensive rehabilitation- after spinal injuries, with damage of spinal cord, tetraplegia or paresis of lower limbs (supplied for the particular stage of rehabilitation or permanently)

3. Technical specification

Elephant chair is a device designed for individual use and must be properly fitted to the patient’s height and weight, with pelottes adjusted to different perimeters of patient’s body.Adjustment and fitting of the device must be done by an authorized service person in order to assure maximum safety and comfort to the patient.

A. Width of pelvis in cmC. Width of chest in cm.J. Length of upper body (from trochanter to the top of patient’s head) in cm.I. Length of shin boneL. Distance form back to calfG. Weight of the user (maximum)

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20-3720-3762-97

23-4430-5475 kg

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4. Elephant- standard equipment

1. Frame with wheels and brakes2. Sit pillow3. Back rest pillow4. Chest supporting pelottes5. Pelvis supporting pelottes6. Vest 7. Wedge8. Foot stabilization with belts

5. Elephant- optional equipment

1. Table 2. Head support 3. Head stabilizing belt

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6. Placing the patient in upright position

Attention: First placing of the patient in upright position takes place usually at home and is assisted by authorized consultant of leading therapist (necessity to adjust the chair to the size and condition of the patient). Later it is continued by trained members of family. Correct fitting of the supports and braces is necessary for safety of the child and guarantees correct rehabilitation.

ATTENTION: Elephant should be used according to this instruction. The patient and the device should be prepared before each usage:

Preparation of the patient- Patient should wear comfortable clothes which do not restrict patient’s movements, shoes should be comfortable and well stabilizing ankle joint (due to hygienic reason and to avoid abrasion it is advisable for the patient to always wear clothes when using the device, skin shouldn’t be naked especially in places of regular contact with upholstery).- In case additional orthopedic devices are necessary (collars, chest support, soft orthopedics, orthopedic shoes) the patient should put them on before sitting in the chair.

ATTENTION: Decision about usage of specific orthopedic devices is made by the leading doctor.

- Drains, bags, catheters, etc. if used, must be secured to function properly but not to disturb the upright standing.

- All exercises must be done in the presence of qualified people.

Preparation of the chair

- Place the device on even surface, with enough space to access the patient and the device, in safe distance from sources of fire and high temperature.

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A

1

B 2

C

D

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- Make sure all parts are in working condition, properly assembled and stable.- Check the condition of wheels and brakes.

- Block the brakes.- Fix the tapes around patient’s feet.

Fitting the device to the patient1. Adjust the height of the foot rest (use screw

A- picture 1) in such a way that tights rest on the sit

2. Adjust the wedge between the tights (forward and backward regulation). The wedge secures the child from sliding down the chair. Adjustment is done with the screw B (picture 2) located under the sit.

3. Adjust the chest pellotes (screw C- picture 3) to the shape of chest than adjust the pelvis pellotes (screw D, picture 3)

1. Upper body is secured with vest. The “hold & pull” clip allows for fast and precise adjustment of those elements to the patient, giving him/her maximum stability and safety.

3. View from the back

E

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5.Back rest should be placed in a position which is comfortable for the child. The angle depends on the dysfunction and child’s position. Adjustment of the back is done with screws E located at the back of the device (picture 5).

5. View from the

6. The head rest should be placed on level of the occipital (in case of optional equipment).

7. The head support belt should be adjusted like in the picture 6 (in case of optional equipment).

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7. Safety rules

1. Use the Elephant chair always according to this instruction2. Before each usage of the Elephant you should:- make sure that all parts have no defects and are correctly assembled and the

device is not damaged or deformed- check if all screws and nuts are tight- check the functioning of clips- check brakes and wheels- make sure all mobile parts are stable and locked- always use safety belts, Velcro tapes must stick at length of 8cm.

3. The device must be used according to its purpose.4. It is not allowed to use the device without assistance of specially trained care taker or medical personnel.5. The device mustn’t be used or left on uneven surface, stairs or slopes.6. The device shouldn’t be used if it is damaged or if any part of it is missing.7. Despite the fact that the device together with upholstery is made of non-flammable materials, you should pay attention to keep it away from fire and sources of high temperature.

The product contains little parts which can be dangerous if swallowed by a child.

In case of any questions, please contact directly the company office (ph. 0048 (0)17 8640470).

WARNINGS: - be careful when opening (cutting) the package not to damage the

chair upholstery- assembly of the chair must be done by a qualified person (dealer,

sales consultant) or specially trained medical staff- the chair is designed for individual use.

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- ELEPHANT should be handled by authorized people like: therapists, doctors, qualified staff - ELEPHANT can be used at rehabilitation wards or at home only when specially trained people are present.

Additional information

- clearing of ELEPHANT should be done according to the instruction “Maintenance and cleaning”

- in case of accidents or damage, contact the dealer which sold you the product.

8. Maintenance and clearing of ELEPHANT as an individual use orthopedic supply and medical device should be maintained clean and used according to the producer’s instruction.

The device should be stored in a clean, dry and aired room.Maintenance and cleaning must be carried out minimum once a

month. Regular cleaning and maintenance of ELEPHANT is necessary to

keep the device in good working and safe condition.

Maintenance of wheels

It is advisable minimum once a month to clean the wheels from all kind of dirt.Lift up the base in order to check if the wheels are properly screwed, not damaged, if the brake stops the spinnig wheels.

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Maintenance of construction and upholstery parts.- make sure that all wooden parts have no splinters, elements of construction are complete and there is no sign of material wear off- make sure that all moving parts are in full working condition, all screws and nuts are tight and complete- make sure the safety belts are not damaged and clips are working properly- check if the table is not damaged (roughness, sharp corners, damaged paint, cleanness)- little dirt can be removed with a soft, moistened sponge; construction should be dried after cleaning

In case of dirty upholstery, the stains should be removed as soon as possible; avoid rubbing the stains, it is advisable to wipe them off with paper towel, clean, soft cloth or tissue. The stain should be removed with a cloth, moistened with normal cleaning detergent. Too wet cloth can cause increase of the stain and damage to the upholstery or the padding inside. The action should be repeated till the stain is totally removed. Remember to remove excessive moisture from the upholstery before next cleaning. After the stain is removed, rinse the upholstery with warm water and white cloth.The upholstery should not be soaked!It is not allowed to use organic solvents or washing powder for chemical wash.Upholstery can be disinfected with any normally available on the market products for disinfection of fabrics. Do not use chlorine to clean the device.The upholstery must be dry before the use.

The producer Akces-MED Sp. z o.o. takes no responsibility for results of cleaning when incorrect cleaning or disinfectant substance was used. It is not allowed to clean, change parts, do maintenance work with the patient inside the device.If there is a need to change parts or do general maintenance of the product, please contact the authorized dealer, at the place of purchasing.

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8. Responsibility of the producer.

AKCES-MED Sp. z o.o. sells the product technically in proper working condition, free of defects: design, manufacture and material etc. There is 24 months guarantee on the rehabilitation chair Elephant, starting on the day of purchasing.

The producer takes responsibility only for hidden faults and technical defects of the product.

The producer takes no responsibility for damages in following cases:

- damages happened as a result of usage of the chair by untrained staff or family- usage of Elephant without assistance of trained staff or family- incorrect assembly of parts and accessories- self modification of parts- damages resulting form incorrect usage (wrong weight, size of chair for the patient)- not following the rules included in this instruction.

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10. Guarantee conditions

1. The producer gives 24 months guarantee on the rehabilitation chair Elephant, starting on the day of purchasing.

2. Any faults occurred in this period will be removed free of charge within 14 days from the date of reporting and delivering of the device to the place of purchasing.3. The costs of delivery are paid by the customer. The customer must deliver

the product to the place of purchasing or to the producer in original packaging, additionally secured from damage. Damages caused by insufficient protection of the parcel are not covered by guarantee. The customer can not ask for gratification if the parcel is labeled and protected incorrectly.

4. Period of guarantee is prolonged by the period of repair.5. Repair under guarantee does not cover included in the instruction activities, which are to be performed by the customer himself/herself at his/her cost.6. Customer has right to exchange the product for a new one in following cases:

- repair is not complete within 14 days- after second repair that makes the usage impossible because the problems occur again.

7. Use the equipment according to the instruction. Usage contrary to the purpose of the equipment and rules of correct exploitation, as well as introduction of any technical changes result in loss of guarantee.

8. Damage of the equipment due to incorrect exploitation, wrong maintenance, wrong storage, mechanical damage as well as natural wear of parts (upholstery and wheels) are not subject of the guarantee. Their repair is done on customer’s cost. 9. Akces-MED advices not to make guarantee repairs in non-authorized services. Such repairs or introduction of changes result in loss of guarantee.10. Guarantee card is valid only if it includes: the date of sales and official stamp of the sales location, signature of the selling person and manufacturing number of the device. Guarantee card should be unexpurgated and without any corrections. 11. Akces-MED offers paid service of the equipment purchased at the

company after the guarantee is finished. 12. In cases not mentioned by this guarantee card, the regulations of Civil Law Code apply.

Please, direct all issues connected with product guarantee to our sales locations, distributors or Akces-MED Sp. z o.o.

Akces-MED Sp. z o.o.ul. Leszka Czarnego 3

35-615 Rzeszówtel. 017 864 04 70fax 017 864 04 71

http:// www.akces-med.come-mail: akces-med@akces-med.com

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27-11-201201-04-2009

Authorised Dealer

date of issue the last update

ORTHOPAEDIC DEVICES MANUFACTURER